According to the Convention on Biological Diversity (CBD), ‘biologics’ means ‘any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use’. Related fields are bioengineering, biomedical engineering, biomanufacturing, molecular engineering. The application of patent law to biotechnological inventions has to deal with a number of particularities. Are biological materials mere ‘discoveries’, and therefore not patentable or man-made ‘inventions’? Limitations to patent rights, in particular a research and experimental use exception, have been considered important for innovation.
Who may bring an action for patent revocation? Such is the fundamental question which has been submitted to the Tribunal de Grande Instance of Paris in a case whose factual circumstances made it very interesting. On 13 September 2010, Omnipharm Limited served a summons on Merial to appear before the Tribunal de Grande Instance of Paris to…
By decision of 14 January 2011, the Court of Turin tackled the issue of the patentability of the intermediate, i.e. the chemical product which represents an obligatory passage of the process of synthesis and the structure of which is successively modified to obtain the wanted substance. The case involved Bayer Schering Pharma against Industriale Chimica…
In the framework of preliminary injunction proceedings instituted by AstraZeneca against the Italian subsidiary of Stada, EG S.p.A., by decision of 11 – 14 February 2011, the IP Chamber of the Court of Turin issued an interesting order concerning the application of Art. 68 (1bis) IP Code, according to which “companies intending to manufacture pharmaceutical…
On 15 March 2011, in a dispute opposing the companies E.I Du Pont de Nemours and Merck and companies Mylan and Qualimed, the Cour d’Appel of Paris confirmed the order handed down on 12 February 2010 by the President of the Tribunal de Grande Instance of Paris, subject-matter of a previous post. The American company E.I. Du Pont de…
The Supreme Court held that the US doctrine of file wrapper estoppel is not applicable under the EPC. According to the Court only Article 69 of the EPC and the Protocol on its interpretation should be applied when determining the scope of a claim. The modifications of the patent application during prosecution cannot be taken…
It has been reported by the Italian Generics Association that on 14 March 2011 the European Commission started infringement proceedings against Italy for an alleged breach of Community law related to Art. 68 (1bis) of the Italian IP Code according to which “companies intending to manufacture pharmaceutical specialties outside patent protection may commence the procedure…
On 10 March, the Court of Justice of the European Union (“CJEU”) issued its long-awaited opinion on the patentability of human embryonic stem cells in Brüstle v Greenpeace C-34/10. Biotechnological inventions are subject to Directive 98/44/EC of the European Parliament and of the Council on the legal protection of biotechnological inventions (the “Directive”). Article 6(1)…
The company governed by the laws of Switzerland, Novartis AG, is the holder of patent EP 0 443 983 entitled “Acyl compounds”, whose subject-matter is a group of antihypertensive compounds, including valsartan, pharmaceutical preparations containing them and processes for the preparation of these compounds. , This patent, filed on 12 February 1991, was to have expired on 12 February 2011. However, Novartis…
As many readers of this blog already know, last October the Italian Antitrust Authority (Autorità garante della concorrenza e del mercato – AGCM), following a complaint filed by Ratiopharm, started investigations against Pfizer aimed at ascertaining whether Pfizer’s behaviour in the enforcement of its patent rights on the drug Xalatan amounts to abuse of a…
H. Lundbeck A/S (hereinafter referred to as Lundbeck) is the holder of European patent EP 0 347 066 entitled “new enantiomers and their isolation”, which designates France and was filed on 1 June 1989; it claims priority of a British patent dated 14 June 1988. The invention relates to the two new enantiomers of the antidepressant drug Citalopram and the use of…
